1.1 The Network shall be called the American College of Radiology Imaging Network (ACRIN).

1.2 The objectives of ACRIN shall include:

1.2.1 To establish an organization of individuals, committees, and institutions with interests in diagnostic imaging and image-guided treatment dedicated to organizing and conducting clinical trials and other studies to improve patient care.

1.2.2 To develop a flexible organizational structure that benefits from easy entry and exit of individuals and entities for trials for which they have interest, expertise, and the capacity to accrue patients.

1.2.3 To evaluate innovative emerging imaging methods that have the potential to improve health and quality of life.

1.2.4 To compare established patterns of imaging diagnosis, staging, and image-guided treatment with alternative approaches to improve the effectiveness of care and reduce its costs.

1.2.5 To decrease the anxiety, pain, and morbidity experienced by patients by hastening the assessment and diffusion of less invasive, less morbidity-inducing technologies.

1.2.6 To determine the value of imaging in reducing the anxiety of individuals who have symptoms but who are free of organic disease.

1.2.7 To disseminate information that accurately depicts the capabilities of imaging technologies to help practitioners most appropriately use imaging technologies in the care of their patients.

1.2.8 Through clinical trials, increase the availability of new, potentially valuable technologies to a broader range of patients, including women, minorities, and economically disadvantaged patients, and to study the value of using these technologies in these populations.

1.2.9 To develop new methods and improve existing methods for the evaluation of imaging technologies.

1.2.10 To attract the best scientists in the imaging community to participate in ACRIN trials and to train new scientists in high quality imaging research.

1.2.11 To define standards for the high-quality use of imaging technologies and disseminate them throughout the practitioner community.

1.2.12 To collaborate with existing NIH cooperative groups and the commercial and payer community to make the best use of Network resources, gain access to innovative technologies, diffuse the cost of conducting trials, and speed patient accrual into ACRIN trials.

2.1 The organization of ACRIN consists of a Headquarters Office that coordinates operations, a Biostatistics and Data Management center (BDMC), a number of scientific, core, and support committees described below, and a number of participating institutions in which studies are performed. The activities and governance of ACRIN, including its scientific strategies and agenda, shall be overseen by its Steering Committee (see section 2.1.1 below). The activities of the Steering Committee shall be reviewed by an Advisory Panel (see section 2.2 below). Standing Committees chaired by members of the Steering Committee fulfill specific Network functions (see section 2.1.6, below).

2.1.1 Steering Committee. The Steering Committee meets regularly by phone and at the Network's meetings. The Steering Committee determines Network policy and resolves problems related to policy matters. It receives recommendations from both the National Cancer Institute Cancer Imaging Program and its Advisory Panel, and makes final determination whether to proceed with those recommendations based on the Network's strategy and available resources. The Steering Committee shall consist of: the Network Chair and Deputy Chair, the Network Statistician, Vice Chairs, and Chairs of standing non-scientific committees (also known as core and support committees).The Network Administrator, the Executive Director of the Headquarters, the Deputy Network Statistician, the BDMC Coordinator, and both the Program Director and the Chief of the NCI Diagnostic Imaging Branch, Cancer Imaging Program (CIP), will be ex officio (non-voting) members. Steering Committee members shall be nominated by the Network Chair and confirmed by the Steering Committee. The Steering Committee has the authority to create and disband committees as needed to advance the work of the Network. A majority vote of the Steering Committee is needed to create or disband a committee. Steering Committee members can be required to resign for cause by a two-thirds vote of Steering Committee members.

2.1.2 The Network Chair is elected by the Steering Committee to serve for a term the length of a funding cycle and may succeed him/herself for one additional funding cycle. The Chair is responsible for the ongoing activities of the Network, interfacing with the Advisory Panel and NCI, managing the activities of Headquarters, chairing the Steering Committee, and planning and chairing the Network meetings. He/she nominates individuals for leadership positions in the Network for election by the Steering Committee.

2.1.2.a. At least one year prior to the conclusion of each Chair's term, the Steering Committee shall either re-elect the Chair (if he/she has served only one term) or elect a new Chair as a means of facilitating the grant renewal.

2.1.3 The Deputy Chair is elected by the Steering Committee for a term the length of a funding cycle and may succeed him/herself for an additional funding cycle. He/she assists the Chair in all of the Chair's responsibilities and assumes the Chair's responsibilities if he/she is temporarily incapacitated or, for any other reason, is unable to fulfill his/her responsibilities. If the Chair is unable to resume his responsibilities, the Deputy Chair serves as Chair until an election for a new Chair can be held.

2.1.3.a. At least one year prior to the conclusion of each Deputy Chair's term, the Steering Committee shall either re-elect the Deputy Chair (if he/she has served only one term) or elect a new Deputy Chair as a means of facilitating the grant renewal.

2.1.4 The Network Statistician heads the BDMC. The term of the Network Statistician is the funding cycle, and he/she may be reappointed. His/her principal responsibilities involve working with ACRIN trial teams to design, implement, and analyze scientifically valid trials of the highest quality.

2.1.5 The Network Chair may, with the majority vote of the Steering Committee, designate Vice Chairs and Core, and Support committee chairs. Each Vice Chair and committee chair fulfills a specific set of responsibilities critical to the operations of the Network. The Vice Chairs and committee chairs, who are members of the Steering Committee, are elected by the Steering Committee for three year terms and may succeed themselves for additional three year terms.

2.1.6 The Network Chair may suggest the formation of standing and ad hoc committees for specific purposes to advance the scientific goals of ACRIN. These may include Scientific Committees. In such instances, the Network Chair will nominate the chair of the committee which shall be elected by a majority vote of the Steering Committee. The newly appointed committee chair may appoint members of his or her committee or operate his/her committee through the sequential appointment and disbanding of ad hoc subcommittees.

2.2 Advisory Panel. An Advisory Panel, of approximately 10 members, will be selected by mutual agreement among the Network Chair, the Program Director, Cancer Imaging Program, and the Chief of the Diagnostic Imaging Branch, Cancer Imaging Program, NCI, who also will appoint the Advisory Panel Chair. Members of the Advisory Panel will be drawn from a variety of fields, and must be experts who are not directly involved in the research activities of the Network. Advisory Panel members will serve three year terms and may be reappointed. The Advisory Panel will review the activities of ACRIN to ensure that the Network's scientific leadership and committee structure:

are adequately responsive to the most promising opportunities in the field;

exhibit flexibility in composition and decision-making;

and are making prioritization decisions free of conflicts of interest.

The Advisory Panel will have a central role in reviewing proposed Network research strategy, making suggestions for altering strategy, and reviewing the progress of the Network on an ongoing basis. No less than annually, the Chair of the Advisory Panel will submit a written assessment of the activities of the Network to the Network Chair, NCI Program Director and Diagnostic Imaging Branch Chief, Cancer Imaging Program. The Advisory Panel may also take on additional oversight duties as agreed upon by these individuals.

3.1 The Steering Committee establishes criteria for institutional participation in ACRIN trials. These criteria are recommended and administered by the Vice Chair for Institutional Participants and the Institutional Participants Committee, working with Headquarters. Institutions that have never previously participated in ACRIN trials complete general participant applications (GQA) that address such criteria as availability of personnel and technology, image quality, medical record-keeping, capacity to adhere to patient accrual and data quality requirements, and IRB and OHRP human subjects assurance. Institutions that have qualified to participate in ACRIN trials via approved GQA's must submit trial-specific applications (TSA) and be approved for individual ACRIN trials.

3.2. ACRIN Headquarters will annually evaluate the performance of all participating institutions. All participating institutions will be annually eligible for on-site audit of trials activities. Headquarters will conduct an audit of each participant at least once every three years. Participants that do not comply with ACRIN standards will first be warned that they need to improve their performance. If they do not bring their performance into compliance within a time period determined by the Steering Committee, they will be dismissed from further participation.

3.3 ACRIN Headquarters will annually evaluate the performance of all participating institutions. All participating institutions will be annually eligible for on-site audit of trials activities. Headquarters will conduct an audit of each participant at least once every three years. Participants that do not comply with ACRIN standards will first be warned that they need to improve their performance. If they do not bring their performance into compliance within a time period determined by the Steering Committee, they will be dismissed from further participation.

4.1 The efficient and timely development of ideas for protocols is the primary responsibility of the Disease Site and Modality (Scientific) Committees. However, protocols can be suggested by members of the Advisory Panel, NCI staff, the Steering Committee, industry, insurers, or any other individual or organization wishing to become involved in ACRIN trials. Studies using ACRIN databases can be initiated by individuals requesting access.

4.2 Ideas for potential ACRIN trials are subject to Network rules for development and consideration. These rules will be codified and available to potential researchers and the general public on the ACRIN Web site. These may be modified from time to time. The Steering Committee makes the final decision concerning which trials ACRIN will pursue based on the Network's overall strategy and the availability of funds.

4.3 Approved ideas for trials undergo full protocol development by the trial team, which is comprised of the proposer(s), members of appropriate Scientific Committees, representatives of Headquarters and the BDMC, and other clinicians, scientists, methodologists, and patient advocates. The resultant trial team is provided access to all relevant Network committees and resources.

4.4 For NCI-funded trials, prior to protocol implementation, ACRIN will submit, as appropriate, concepts and/or protocols for review to CIP/CTEP Imaging Coordinator and the Protocol and Information Office/CTEP/NCI.

5.1 ACRIN meets at least annually to conduct its decision-making and review its activities. Notification of meetings will be by ACRIN Headquarters. The Network Chair is responsible for meeting planning, in consultation with the Network Statistician and Headquarters. Meeting participants will include: members of the Steering Committee; chairs of Scientific Committees; members of the Data Safety and Monitoring Committee (DSMC) and Advisory Panel; Headquarters personnel; BDMC investigators; representatives of participating institutions; trial teams; NCI staff; research associates, patient advocates, representatives of the NCI Cancer Imaging Program, and other invited participants important to the conduct of ACRIN activities. In addition, all interested parties are invited to attend.
The purposes of these meetings include:

6.1 Headquarters is responsible for managing all major organizational activities of ACRIN, including financial management, preparation and scheduling of meetings, development and maintenance of a Web site, organization and maintenance of databases, and communications among Headquarters, the BDMC, the Chair, NCI, Steering Committee members, investigators, and participant institutions.

6.2 Headquarters will not move its site with changes in Network leadership during a grant cycle.

7.1 The Biostatistics and Data Management Center operates under the leadership of the Network Statistician. The BDMC: provides support and methodological leadership to ACRIN investigators in the design, development and implementation of Network studies; works with ACRIN investigators in the design, development and implementation of data collection forms and procedures; carries out appropriate pilot testing of protocol implementation and data collection procedures; carries out the data collection in each ACRIN protocol and develops and maintains primary and analytic databases; continually monitors and verifies the quality of the data, including checks of accuracy, completeness, and timeliness; implements procedures for guaranteeing the integrity of the database; continually monitors and verifies compliance with all aspects of the protocol and designs and implements rigorous quality control procedures for imaging and other studies; develops and implements a process for performing site audits and generating timely audit reports; designs and performs interim and final analyses of the data and generates relevant reports; provides methodologic leadership and support in summarizing and interpreting study findings and in preparing abstracts and manuscripts; addresses methodological issues arising in the design and analysis of ACRIN studies; and carries out research on statistical methodology for the evaluation of imaging.

7.2 The Network Statistician will head the BDMC. He/she will be the awardee of the NCI grant that is linked to the funded ACRIN Headquarters proposal.

8.1 ACRIN will establish a Data Safety and Monitoring Committee (DSMC). The DSMC will consist of no more than 10 members, having diverse expertise related to the objectives of ACRIN. A quorum for DSMC meetings is required and is defined as 3/4 of the appointed members. The Network Chair, the Head of the BDMC, and one or more NCI staff members will be ex officio members. Members of the DSMC are independent of study leadership, and must clearly be free of conflicts of interest. The DSMC must have formally documented policies and procedures, and these must be approved by the Diagnostic Imaging Branch Chief, Cancer Imaging Program, NCI. ACRIN must comply with the policies and procedures of the DSMC. The NCI Program Director, assisted by NCI staff, will assess Network compliance with NCI-established policies on DSMC's for multi-center Phase III trials.

The main objectives of the independent DSMC are to:

Ensure that patients in trials are protected and that their interests are not made secondary to the interests of scientific investigation.

Ensure that evaluation of interim results and decision- making about continuation, modification, termination of accrual, and reporting of results are made competently based on thorough evaluation.

Ensure that the credibility of trial reports and ethics of trials conduct are above reproach with no actual or possible appearance of professional or financial conflicts of interest.

Enable physicians entering patients to remain free of knowledge of interim efficacy and toxicity data. This permits physicians to continue to approach their patients honestly and obviates the need to modify informed consent based on statistically insignificant interim results.

Enable study leadership to remain free of knowledge of (often unreliable) interim efficacy and toxicity data, so that they may deal honestly with their peers in encouraging them to enter patients in the study and so that they do not put themselves or the study at risk by inadvertently divulging interim results. The DSMC will meet at Network meetings. The DSMC will review interim analyses of study outcome data (prepared by the Network Statistician) at intervals specified by the protocol, or upon special request, and, when appropriate, to recommend modification to or termination of the study based on these analyses. The committee will also determine if and to whom interim outcome results should be released prior to the study reporting results outlined in the protocol. The Network will also utilize the expertise of the DSMC to address issues of reporting or deferring reports on continuing companion studies, such as quality of life or outcomes studies.

8.2. ACRIN may establish one or more separate DSMC's to address particularly large or complex trials and/or trials demanding specific expertise for which its principal DSMC is not equipped. The qualifications and rules governing the principal DSMC shall also govern these trial-specific DSMC's.